ORO conducts Focused Reviews to assist facilities in complying with VA and other Federal requirements for research, especially in areas that may be of special concern at individual facilities or across the VHA research system as a whole. ORO Focused Reviews are narrower in scope than Combined Program Reviews (CPRs) and focus on individual facility research program oversight areas and/or specific issues for review. Unlike CPRs, ORO’s Focused Reviews are not cyclical. ORO’s decision to conduct a Focused Review, and the scope of said review, are guided by: the size and/or complexity of a facility’s research portfolio; specific issues of concern identified by ORO in an earlier CPR or through other mechanisms (e.g., Facility Director’s Certification, reports of noncompliance, etc.); known VHA-wide research compliance issues that might also be of relevance at a given facility; and/or other factors.
The process for conducting a Focused Review is dependent on the nature and extent of the issues that are the focus of the review. Typically, an ORO Focused Review will involve some combination of the following methodologies: interviewing facility leadership, research administrative staff, research oversight committee members and staff, investigators, and/or other personnel associated with the facility’s research compliance program; reviewing facility research policies, procedures, protocols, and other documentation; and conducting physical inspections of research areas. With regard to the review of individual protocols and inspection of research areas, ORO may employ a “sampling” approach whereby it reviews select protocols and inspects a subset of the research area(s) so as to evaluate whether actual practices comport with regulations and policies governing the review, approval, and conduct of research at a facility.
Focused Review Procedural Overview∗
• ORO will contact the facility approximately 2-3 months prior to the Focused Review to discuss dates for pre-site visit interviews and the on-site portion of the review.
• ORO will create a case for tracking purposes.
• ORO will send a formal Letter of Notification (LON) approximately 1.5-2 months prior to the on-site portion of the Focused Review. The LON will include a list of documents the facility will need to provide to ORO, key personnel to be interviewed, meeting space and logistical requirements, and proposed agendas for videoconferencing and the on-site portion of the Focused Review.
• The facility will upload requested documents to ORO’s secure SharePoint site approximately 4 weeks prior to the Focused Review. Documents to be uploaded in advance of the on-site portion of the Focused Review may include: policies and procedures pertaining to the facility’s research oversight program (i.e., Human Research Protections Program (HRPP), Research Information Security Practices (RISP), Animal Care and Use Program (ACUP), Research Safety and Security Practices (RSSP), or General Research Administration (GRA)) that is the focus of the review or that is associated with the discrete issue that is the focus of the review; research oversight committee rosters and meeting minutes; memoranda of understanding governing reliance on external oversight committees; external and internal research inspection reports; study protocol inventory lists and select protocols (if available electronically); assurance- and accreditation-related records; research audit and training records; hazardous agent and electronic information system inventory lists; and other documents as specified by the team conducting the site visit.
• Facility personnel may be requested to complete checklist(s) associated with the facility’s research oversight program (i.e., HRPP, RISP, ACUP, RSSP, or GRA) that is the focus of the review or that is associated with the discrete issue that is the focus of the review. (see http://www.va.gov/ORO/orochecklists.asp)
• Interviews will be conducted with key facility personnel involved with the research program. These interviews may occur via video/teleconference prior to the on-site portion of the review and/or during ORO’s on-site visit. Depending on the issue that is the focus of the review, key personnel that will be interviewed may include:
o Medical Center Director
o ACOS/R and AO/R
o R&DC Chair/Coordinator
o IRB Chair/Coordinator
o Principal Investigators (PIs) and study personnel
o SRS, IACUC, and IBC Chairs/Coordinators
o Facility Safety Officer and Industrial Hygienist
o Facility Services/Engineer Representative
o VMU Supervisor and Chemical Hygiene Officer
o Veterinary Medical Officer
o Police Services Representative
o Occupational Health Representative
o Research Compliance Officer
o Privacy Officer, Information System Security Officer, and OIT Area Manager
o Research Pharmacist
• ORO on-site activities may involve, if and as applicable:
o Entrance briefing with VHA facility leadership (only at MCD request)
o Walk-through of research areas with possible ad hoc interviews of PIs and study personnel
o Interviews and/or follow-up interviews with facility personnel, including PIs and other study personnel
o Document review, including review of select protocols
o Exit briefing with VHA facility and Research Service leadership
• ORO will issue a written report describing any findings of noncompliance identified during the course of a Focused Review and required actions to remediate the noncompliance. ORO’s report may also contain observations, which do NOT constitute findings of noncompliance but may constitute vulnerabilities that facility personnel may consider addressing so as to strengthen their research oversight programs.
o A draft of ORO’s written report is provided to VHA facility leadership for review and factual correction within approximately 70 days of ORO’s on-site exit briefing.
o The final version of ORO’s written report is issued within approximately 90 days of ORO’s on-site exit briefing.
o ORO’s final report is transmitted to the VHA facility Director, applicable Network Director, and VHA leadership.
• If applicable, facility personnel must submit a Remedial Action Plan to ORO within 30 days after receipt of the final report. The plan must include specific remedial actions and timely completion dates for each finding of noncompliance in the report.
o Except where remediation requires substantial renovation or fiscal expenditure, hiring, legal negotiations, or other extenuating circumstances, remedial actions must be completed within 180 calendar days after any determination of noncompliance.
o Where remedial actions cannot be completed in 180 calendar days, the VA facility Director must provide ORO with an acceptable written justification and an acceptable timeline for completion.
o ORO will monitor remediation efforts until satisfied.
∗NOTE: The procedures described in this section apply to Focused Reviews with on-site review portions. ORO may conduct Focused Reviews completely remotely (i.e., without an on-site review portion). For such reviews, the procedures described in this section are modified accordingly.